NNVC stock surged 12% higher in early trading on June 25, 2020. There is no new press release or catalyst so the move appears to be tied to the general outflow of money from reopening stocks going back into coronavirus biotechnology stocks.
The last major coronavirus news announcement from the company came on June 9, 2020, when NanoViricides reported that it had signed a Memorandum of Understanding, or MoU, with respect to anti-viral treatments for coronavirus derived human infections with TheraCour Pharma.
NanoViricides said in a release, “The MoU specifically provides a limited, exclusive license to all research and development in the Field for further research and development purposes towards human clinical trials. NanoViricides intends to retain an independent consultant for the evaluation of the assets in order to develop the full license agreement. NanoViricides has been working on drug development to treat the SARS-CoV-2 infection in COVID-19 patients since January, 2020. Prior to this, the Company had engaged in limited research and development work for the treatment of MERS coronavirus during 2014 which allowed for rapid drug candidate identification against SARS-CoV-2. The MERS coronavirus program was set aside as the 2014 outbreak remained contained. The Company has found that the broad-spectrum anti-coronavirus drug candidates that it is developing were several times more effective than favirpravir in cell culture assays against two different coronaviruses, namely hCoV-229E, and hCoV-NL63. These circulating coronaviruses use distinctly different, but related cellular receptors, namely APN for hCoV-229E and ACE2 for hCoV-NL63. The Company believes the fact that these nanoviricides anti-coronavirus drug candidates are highly effective against two distinctly different coronaviruses that use different cellular receptors is very significant. Specifically, it provides a rational basis to scientists indicating that even if the SARS-CoV-2 coronavirus mutates, the nanoviricides can be expected to continue to remain effective. The Company has also found that these drug candidates showed strong effectiveness in an animal model of human coronavirus disease, potentially superior to remdesivir in this particular model, although no firm conclusions to that effect can be drawn with the limited dataset at present. The Company employed hCoV-NL63 in this animal study, because hCoV-NL63 binds to the same cell receptor, namely ACE2, as does SARS-CoV-2 and the 2002-03 SARS-CoV. NL-63 causes clinical pathology in humans that is similar to SARS-CoV-2, but much milder. Thus this virus is expected to be a good surrogate for SARS-CoV-2. The Company believes that it now has broad-spectrum anti-coronavirus drug candidates that are worthy of human clinical trials based on their effectiveness in cell culture and animal models. Importantly, nanoviricides are designed to act by a novel mechanism of action, trapping the virus particle like the “Venus-fly-trap” flower does for insects. Antibodies, in contrast, only label the virus for other components of the immune system to take care of. It is well known that the immune system is not functioning properly at least in severe COVID-19 patients. Prior to filing for human clinical trials, NanoViricides plans on conducting studies to further determine the effectiveness against SARS-CoV-2, perform drug development studies for safety/toxicology, and request a pre-IND Meeting with the FDA for regulatory guidance. Human coronavirus NL63 uses the same ACE2 receptor as the SARS-CoV-2 that causes CoVID-19. Both in terms of its clinical pathology, and its receptor usage, it is known to be very similar to SARS-CoV-2, except much milder. Therefore the Company believes hCoV-NL63 is a good surrogate model for therapeutics development against SARS-CoV-2. HCoV-NL63 can be studied in a BSL2 lab whereas SARS-CoV-2 currently requires a BSL3 or BSL4 facility.”
Unrelated to COVID-19, the company announced on June 23, 2020, that it continues to advance its first drug candidate, namely NV-HHV-101 skin cream, for the treatment of shingles rash as its first indication, towards human clinical trials. The company is now in the process of writing and completing its first IND, or investigational new drug, application to the FDA, which includes protocols for human clinical studies, with the help of its several regulatory consultants. This application covers the indication of the company’s drug, namely, NV-HHV-101 skin cream for the treatment of shingles rash, caused by VZV, or varicella-zoster virus.
The IND-enabling and required pre-clinical studies have been completed, and reports of almost all of the analyses of the samples resulting from these studies are being circulated between parties involved for completion. The company is in the process of identifying and selecting appropriate partners and collaborators for the intended Phase1/2a human clinical studies for this drug candidate. The company cannot project an exact date for filing an IND because of its dependence on a number of external collaborators and consultants and the effects of recent COVID-19 restrictions. The company has undertaken cGMP manufacture of the drug product, namely, NV-HHV-101 skin cream, indicated for the topical treatment of shingles rash, for supplying anticipated Phase I human clinical trials at its own facility.
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